Minimally invasive treatments including endovascular therapies are increasing preferred and used instead of traditional “open surgical” interventions whenever possible. Endovascular techniques may be used to diagnose and/or treat a broad range of pathologies. Therapies may range from critical limb ischemia and aneurysm repair to ischemic stroke therapies and treatment of vascular stenoses. All endovascular techniques require a vascular access site for device introduction into a vascular lumen. For treatment personnel (e.g., surgeons and those assisting them), choosing the best site for an initial puncture and the best path for the introduction of devices poses a challenge for any endovascular procedure. Vascular access requires a complex balance of entry into and closure of a vascular entry site, most preferably with a minimum of discomfort and post-operative risk to the patient being treated.
Examples of access procedures may include, but are not limited to, central line placements (e.g., power ports, peripherally inserted central catheters (PICCS), dialysis/pheresis catheters), arterial access, peritoneal access, spinal access, and venous access. For example, the maintenance and longevity of vascular access remains one of the most problematic topics in the care of dialysis patients. Although much attention has focused on neointimal hyperplasia, the repetitive trauma to vessel walls by dialysis needles causes significant cumulative damage that has not been broadly investigated. Commercial needles have beveled tips with intentional cutting surfaces to ease manual insertion. Several complications may arise, particularly with repeated vascular access, including—for example—hematoma formation, clotting, aneurysm, and infections at the cannulation sites.
Several approaches attempt to avoid these complications. Examples of these include the “ladder approach” where consecutive dialysis puncture sites are successively and systematically located a small distance away from each prior dialysis puncture site, allowing the previous sites to heal. After a time the previous sites are reused. Another technique uses a region for repeated punctures. This often results in local aneurysmal dilation at or near the puncture site of the vessel. Another approach utilizes the precise placement of the needle in the same spot as close as possible, repeatedly using—as nearly as possible—the same insertion site, depth, and angle. This approach, known as the “button-hole” technique appears to lead to the longest lasting use of an arteriovenous (AV) fistula type of dialysis. Similar complications may arise from single-access procedures such as, for example, femoral access for cardiac stent placement, where the access site may be at risk of hematoma formation or infection. These risks may be reduced by minimizing the amount of time required for the body to seal the blood vessel wall after a procedure (and, by extension, between successive procedures).
Accordingly it is desirable to provide a vascular access needle that causes minimal trauma to a penetration site, from which the patient's body may more rapidly heal.